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Bioequivalence and Evaluation Parameters Based on the Pharmacodynamics of Miglitol in Healthy Volunteers
Author(s) -
Yan Juan,
Li XiaoMin,
Zhang YanXin,
Xu SuMei,
Liu WanLi,
Guo Jie,
Hu XiaoLei,
Zou Ting,
Xu YuYing,
Xu PingSheng
Publication year - 2021
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.873
Subject(s) - medicine , bioequivalence , pharmacodynamics , pharmacology , pharmacokinetics , traditional medicine
The aim of this study was to explore the bioequivalence of miglitol based on pharmacodynamic properties. The study was performed as a single‐dose, randomized, open‐label, 3‐period, 3‐way crossover trial over a 7‐day washout period. Forty‐eight subjects were randomly assigned into 3 groups: (1) miglitol test formulation/sucrose coadministration, (2) miglitol reference formulation/sucrose coadministration, and (3) sucrose administration alone. Serum glucose concentrations were measured by the hexokinase detection method. The peak serum glucose concentration (C max ) and the area under the serum glucose concentration‐time curve through 4 hours (AUC 0‐4h ) were used as the main pharmacodynamic parameters to evaluate bioequivalence. The 90% confidence intervals for the geometric mean ratios of C max and AUC 0‐4h were 94.81%‐101.07% and 98.82%‐100.72%, respectively, which were all within the bioequivalence range of 80.00%‐125.00%. The test and reference formulations of miglitol were pharmacodynamically bioequivalent during the trial.